Table 3.

—[Section 2.1.2] Summary of Findings: IV r-tPA Initiated Between 3 and 4.5 h in Patients With Acute Ischemic Stroke^10-11

Outcomes	No. of Participants (Studies) Follow-up	Quality of the Evidence (GRADE)	Relative Effect (95% CI)	Anticipated Absolute Effects, Time Frame 90 d
				Risk With No IV r-tPA	Risk Difference With IV r-tPA (95% CI)
Overall mortalitya	1,620 (5 studiesb) 90 d	Lowc,d due to inconsistency, imprecision	OR, 1.22 (0.87-1.71)e,f	120 deaths per 1,000g	23 more deaths per 1,000 (from 14 fewer to 69 more)
Good functional outcome,h mRS 0-1	1,620 (5 studiesb) 90 d	High	OR 1.34 (1.06-1.68)e,f	350 excellent outcomes per 1,000i	69 more excellent outcomes per 1,000 (from 13 more to 125 more)

NIHSS=National Institutes of Health Stroke Scale. See Table 1 and 2 legends for expansion of other abbreviations.

^aFatal ICH not reported separately because it is captured in overall mortality. There is a significantly increased risk of fatal ICH associated with thrombolytic therapy across all time to treatment strata up to 6 h; OR=3.70 (95% CI, 2.36-5.79). Absolute risks are 3.5% with tPA and 0.8% with placebo; seven studies.

^bATLANTIS, ECASS I (1995), ECASS II (1998), ECASS III (2008), and EPITHET.

^cI²=70%.

^d95% CI includes both (1) no effect and (2) appreciable benefit or appreciable harm.

^eBased on Lees et al.¹⁰

^fThis is an adjusted OR that takes differences in baseline NIHSS score, age, and BP into account.

^gBaseline mortality rate (217 of 1,822=11.9%) derived from placebo arms of tPA trial (NINDS, ECASS, ATLANTIS, and EPITHET).

^hSymptomatic nonfatal ICH not reported separately in table as it is captured by good functional outcome. Symptomatic nonfatal ICH more likely than placebo in the 3-6-h time window. OR=3.34; 95% CI, 2.4-4.7; 8.4% vs 2.5%; six studies (three ECASS trials, two ATLANTIS trials, and EPITHET 2008). Data from Wardlaw et al.¹¹

ⁱBaseline good functional outcome percentage (641 of 1,822=5=35.2%) derived from placebo arms of tPA trials (NINDS, ECASS, ATLANTIS, and EPITHET).